Mindray Zonare ZS3 Bedienungsanleitung

ZS3 Ultrasound System

Instructions for Use

For this Instructions for usemanual, the issue date is 2018-12.

ZONARE, the ZONARE logo, ZS3 and z.onepro are all trademarks of Shenzhen Mindray Bio-Medical Electronics Co.,

Ltd. All other trademarks are the property of their respective holders.

The ZS3 Ultrasound Platform and products derived there from (for example, but not limited to, the ZS3 and the

z.onepro with and without the SP UI option) is covered by one or more of thefollowing patents:

6,251,073; 6,569,102; 6,618,206; 6,663,567; 6,685,645; 6,733,455; 6,773,399; 6,866,631; 6,866,632; 6,896,658;

6,936,008; 6,980,419; 6,997,876; 7,022,075; 7,087,020; 7,226,416; 7,238,157; 7,352,570; 7,361,145; 7,510,529;

7,627,386; 7,382,309; 7,699,781; 8,002,705; 8,226,561; D461,814; D462,446; D467,002; D469,539; D469,877

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan,

Shenzhen, 518057, P.R.China

Shanghai international Holding Corp. GmbH(Europe)

Eiffestraβe 80, 20537 Hamburg, Germany

Technical Support

North America and Asia:

Phone support: 1-877-913-9663 or 1-650-316-3199 option 7 (ultrasound)

Email: techsupport@mindray.com

Sales support: 1-877-966-2731,

Email: salessupport@mindray.com

www.mindraynorthamerica.com

Europe: Phone support: +49 (913) 1974-9412

Email: info@mindray.com

www.mindray.de

Europe and Asia:

Address: Mindray Building, Keji 12th Road South, High-tech industrial park,

Nanshan, Shenzhen 518057, P.R.China

E-mail Address: service@mindray.com

www.mindray.com

Tel: +86 755 81888998

Fax: +86 755 26582680

CAUTION

United States Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).

III

Contents

Contents.......................................................................................................................................III

Intellectual PropertyStatement ........................................................................................................IV

Responsibility on the Manufacturer Party .......................................................................................IV

Warranty.............................................................................................................................................V

Exemptions......................................................................................................................................V

Introduction.........................................................................................................................1

GettingStarted ....................................................................................................................6

3. Imaging.............................................................................................................................18

Transducers and Needle-Guided Brackets...........................................................................31

Transducers .......................................................................................................................................31

Needle-guided Bracket .....................................................................................................................42

TEE/Laparoscopic Transducers.......................................................................................................45

Wearing the Probe Sheath ................................................................................................................52

Transducer Tracking .........................................................................................................................55

Measurements and Calculations..........................................................................................57

Annotations, Arrows, and Body Markers...............................................................................66

Archiving,Review and Management....................................................................................69

AdvancedFeatures and Options........................................................................................76

Contrast Enhanced Ultrasound (CEUS).........................................................................................76

Contrast Enhanced Ultrasound Quantification Imaging (CEUS-QI)..........................................80

Elastography...................................................................................................................................83

Tissue Tracking Quantitative Analysis (TTQA)..........................................................................89

3D & 4D Imaging with Advanced Lighting...........................................................................92

10.

Needle Optimization Mode (For Improved Needle Visualization) .......................................99

11.

Protocols.........................................................................................................................101

12.

Stress Echo.....................................................................................................................103

13.

Setup..............................................................................................................................107

14.

System Security..............................................................................................................111

15.

Maintenance ...................................................................................................................116

16.

Safety.............................................................................................................................118

17.

AcousticOutput...............................................................................................................128

18.

DisplayAccuracyandPrecision........................................................................................133

19.

GuidanceDocuments.......................................................................................................135

20.

StandardsandCompliance..............................................................................................136

21.

ProductLabeling..............................................................................................................143

22.

Specifications..................................................................................................................144

Intellectual PropertyStatement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)

owns the intellectual property rights to this Mindray product and this manual. This manual may

refer to information protected by copyright or patents and does not convey any license under the

patent rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of

the information in this manual in any manner whatsoever without the written permission of

Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

derivative work of this manual in any manner whatsoever without the written permission of

Mindray is strictly forbidden.

, and are the trademarks, registered or otherwise, of Mindray in China and

other countries. All other trademarks that appear in this manual are used only for informational or editorial

purposes. They are the property of their respective owners.

This posting serves as notice under 35 U.S.C. §287(a) for Mindray patents:

http://www.mindrayna.com/patents.

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable for

errors contained herein or for incidental or consequential damages in connection with the

furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product, only if:

all installation operations, expansions, changes, modifications and repairs of this product are

conducted by Mindray authorized personnel;

the electrical installation of the relevant room complies with the applicable national and local

requirements; and

the product is used in accordance with the instructions for use.

Note

This equipment must be operated by skilled/trained clinical professionals.

Warning

It is important for the hospital or organization that employs this equipment to carry out a

reasonable service/maintenance plan. Neglect of this may result in machine breakdown or

personal injury.

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS

FOR ANY PARTICULAR PURPOSE.

Exemptions

Mindray's obligation or liability under this warranty does not include any transportation or other

charges or liability for direct, indirect or consequential damages or delay resulting from the

improper use or application of the product or the use of parts or accessories not approved by

Mindray or repairs by people other than Mindray authorized personnel.

This warranty shall not extend to:

Malfunction or damage caused by improper use or man-made failure.

Malfunction or damage caused by unstable or out-of-range power input.

Malfunction or damage caused by force majeure such as fire and earthquake.

Malfunction or damage caused by improper operation or repair by unqualified or

unauthorized service people.

Malfunction of the instrument or part whose serial number is not legible enough.

Others not caused by instrument or part itself.

ZS3 Instructions for Use

1 | P a g e

Introduction

United States Federal Law restricts this device to sale by or on the order of a

licensed healthcare practitioner, licensed by the law of the jurisdiction in which

they practice, to use or order the use of this device.

Only qualified personnel should perform ultrasound scanning of human

subjects for medical diagnostics.

This ultrasound system meets the acoustic output emission guidelines established by the

U.S. Food and Drug Administration (FDA). Acoustic output quantities have been

measured, and are displayed, in accordance with the standards listed under Guidance

Documents.

Indications for Use

The ultrasound system is intended for use by a qualified physician for ultrasound evaluation

of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal,

thoracic(cardiac), and vascular); Intra-operative (Neuro); Laparoscopic; Pediatric; Small

organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans-

rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional);

Musculoskeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac);

Intra-cardiac; Peripheral vessel.

Note: The availability of application may be limited based on country or region of use.

Device Description

The ZS3 Ultrasound Platform and products derived there from (for example, but not limited

to, the ZS3 and the z.onepro with and without the SP UI option) is used for ultrasound

evaluation of the following applications: Laparoscopic, Fetal, Abdominal, Intra-operative,

Pediatric, Ophthalmic, Small Organ/Parts (breast/testes, thyroid, etc.), Transvaginal,

Transrectal, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular,

Tissue Elasticity, Contrast Imaging, Musculoskeletal, Superficial Musculoskeletal and

Peripheral Vascular applications. Users include ultrasound imaging technicians

(sonographers) and physicians. This ultrasound system may be used in a hospital (e.g.

imaging laboratory, emergency room, patient bedside, and operating room), medical clinic,

physician’s office or a mobile imaging center.

The ZS3 Ultrasound Platform consists of two major components: 1) Cart; and, 2)

Transducer(s). The Cart contains the software driven imaging electronics and user

interfaces (keyboard, monitor, handles, etc.). It houses the microprocessor, memory,

amplifiers and power supplies for the microprocessor. It sends electrical currents to and

receives electrical pulses from the compatible transducers. The Cart performs the

calculations involved in processing the data to produce the displayed ultrasound images.

ZS3 Instructions for Use

2 | P a g e

Standard Configuration

Main unit

Storage bins

System software

Accessories:

Power cables

Operator's manual

Operator’s manual in multi-language (disk)

Options

No.

Item

Remarks

CW Enable

ECG Enable

Strain Elastography

ARFI

2D SWI

Small Parts CEUS

Not

applicable for the FDA

region.

GYN CEUS

Abdominal CEUS

Only applicable for liver in the

FDA region

Cardiac CEUS

Only applicable for LVO in

the FDA region

10.

CEUS QI

Only applicable for liver and

LVO in the FDA region

11.

CEUS Sequence

Only applicable for liver and

LVO in the FDA region

12.

HD Scope

13.

Advanced Cardiac

Including AutoEF and

Expanded Echo Calcs.

14.

Smart OB/NT

15.

AutoIMT

16.

Stress Echo

17.

Total Recall

18.

Protocol

19.

Needle OPT

20.

Anat Mmode

21.

TTQA

22.

Battery Pack

23.

ECG cable

24.

Barcode Reader

25.

USB Foot Pedal

26.

Ultrasound gel warmer assembly

Including ultrasound gel

warmer and bracket.

ZS3 Instructions for Use

3 | P a g e

No.

Item

Remarks

27.

Intra-cavitary probe holder pack

Installed in the right side.

Including intra-cavitary probe

holder and bracket.

Not applicable for the FDA

region.

28.

Printer bracket

29.

SONY UP-D711MD black/white

printer pack

30.

SONY UP-D711MD printer bracket

pack

31.

Hook

32.

Keyboard protective cover

33.

Wireless Ethernet Routers and

Bridges

Peripherals Supported

Item Model

Digital black/white video printer SONY UP-D711MD

Digital color video printer SONY UP-D25MD

Note: The availability of options may be limited based on country or region of use.

The following symbols may be used in this document or elsewhere in product labeling.

Symbol

Description

Informationthat may relate to safety of the patient, theoperator, or theequipment

A type BF patient-applied part (B= body, F= floating applied part)

A type CF patient-applied part (C= cardiac, F= floating applied part)

Alternating current (AC)

Direct current (DC)

Date of manufacture

Manufacturer

Key to Symbols

ZS3 Instructions for Use

4 | P a g e

Caution: ESD sensitive

Recyclable material

VVoltage

Hz Cycles per second

Waste Electrical & Electronic Equipment Standard

Applies to EU Member States only: this system should not betreated as household waste.

Mindray meets the WEEE Standard. For more information on returning or recycling this

system, please contact Shenzhen Mindray Bio-Medical Electronics Co. or the distributor

from whom you purchased the system.

Consult the Instructions for Use

Serial number

Authorized representative in the European Community

Catalog number

Shipping & Storage: Fragile

Shipping & Storage: Keep dry

Shipping & Storage: Temperature limits

Shipping & Storage: This side UP

Shipping& Storage: Do not stack above this container

Shipping & Storage: Humidity limits

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